Change Control Specialist II

3 weeks ago


Lansdale, United States Insight Global Full time

One of our large pharmaceutical clients is actively looking for a Change Control Specialist to join their growing team in Lansdale, PA (hybrid schedule). This individual will be owning the entire change control lifecycle process and each change that occurs in the manufacturing process needs to be assessed and justified. This includes technical information on the process development studies performed to support the modifications, detailed implementation tasks with associated acceptance criteria, and confirmation from all affected stakeholder groups to ensure only positive impacts. They will be working with product components, primary packaging, or raw materials to help support the all execution. Main responsibilities include having meetings with vendors, change owners, and product owners to gather information to prepare change requests, writing & authoring memos/change control documents. They will need to be able to read SOPS and understand the components surrounding it. These engineers will ensure the process changes are appropriately managed via the Global Change Management and IPI quality systems and will partner with technical, quality and operations stakeholders to implement the changes within a plant site and get final approval. This is a hybrid role, 3 days onsite, 2 WFH.

Qualifications:

  • 2+ years of experience working within change control management
  • GMP Pharmaceutical industry experience
  • Technical Writing & SOP writing experience
  • Bachelors Degree in a Science or Engineering related field
  • Experience with SAP or IPI

Pay: $40.00-$50.00/hr (flexile based on experience)

Hours: Monday-Friday, 9:00am-5:00pm

Schedule: 3 days onsite & 2 WFH

Hiring Method: Multiyear contract After 1 year on contract, the individual will have the opportunity to apply for a permanent role or have their contract renewed for another year

Benefits: Medical, Dental, Vision and 401K plans available

Exact compensation may vary based on several factors, including skills, experience, and education. Benefit packages for this role will start on the 31st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.


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